Goal of the current page
- Describe the business goals for eHDSI and classify them by type. One or several business goals can be linked with one or several business requirements.
- Describe the scope of eHDSI, with focus on what is out of scope for the current version of eHDSI. In terms of content, the information was taken from the eHDSI Functional Requirements documents. The Business Analysis and Requirements Management scope/out of scope items were added to the Approach page of this service.
eHDSI Business Goals
The following table presents an overview of the business goals. The business requirements are linked to one or several business goals.
|#||eHDSI BUSINESS GOAL TYPE||eHDSI BUSINESS GOAL DESCRIPTION||LINKED BUSINESS REQUIREMENT|
|1||Health Professional (HP) Identity||Ensure that the HP identity is certain||Ensure Health Professional (HP) Identification, Authentication and Authorization|
|2||Patient Identity||Ensure that the patient's identity is certain||Ensure Patient Identification|
|3||Trust||Ensure trust between countries||Ensure Health Professional (HP) Identification, Authentication and Authorization|
|4||Interoperability||Enable the exchange of health data between countries|
|5||Processing of personal data||Ensure lawful processing of personal data|
|6||Patient safety and security of health data|
|7||Service Confidentiality||Ensure confidentiality of the service|
|8||Data Integrity||Ensure the integrity of the exchanged data|
|9||Service Availability||Ensure the availability and avoid degradation of the service.||Ensure Service Availability|
|10||Service Performance||Ensure Service Performance|
|11||Data traceability, auditability and non-repudiation|
eHDSI IN SCOPE description
|#||eHDSI SERVICE IMPACTED|
|1.||Patient Summary (PS)|
At European level, it has to be assumed that the patient may have more than one electronic PS, in one or many countries, made available abroad in a structured way compliant with eHDSI PS specification.
But, in the current version of eHDSI, only one common structured eHDSI PS per country will be provided. The current approach is that only the PS of country A will be shown to the HP of Country B.
|2.||ePrescription (eP)||The prescriptions considered for the eHDSI are medicinal products intended for human use, elaborated from an industrial process, prescribed for out-patients (not to be dispensed in the Hospital), and dispensed in Community Pharmacies. These medicinal products must be produced by a registered pharmaceutical manufacturer and hold a current 'marketing authorization' (licence).||ALL|
eHDSI OUT OF SCOPE description
|#||eHDSI SERVICE IMPACTED|
OUT OF SCOPE
|1||ALL||A single (unique) stored European Patient Summary.||ALL|
Providing the Health Professional in Country B with all the related health information of the patient, such as for instance: complete electronic patient record, all health encounters, all laboratory tests, all X-rays exams etc).
|4||ALL||Management of the authentication process of the Health Professionals in their systems.||ALL|
|5||ALL||Management of the identification/authentication/authorization process of the patient.||ALL|
Ensure Consent Management by deciding on whether a certain request for data is legitimated by the consent of the patient.
New item added as out of scope, because each MS needs to analyse their specific legislation as concerns consent management, in accordance with GDPR and the exceptions foreseen by their national laws (where applicable). It is MS decision if they need consent or they have other (legal) basis for processing citizens' personal/health data, as well as how they should manage their responsibilities related to data protection.
Transfer of clinical information from Country B to Country A.
|8||Patient Summary||The additional use case ADD_Handle Patient's access to existing Patient Summaries is out of the current eHDSI scope. This use case refers to the possibility for the patient to access his/her Patient Summary, transcoded and translated in the language of the health professional in the country of treatment.||ALL|
Providing several Patient Summaries of the same patient to Country B.
|10||Patient Summary||It is out of scope in eHDSI other potential use of the PS information (e.g.: public health, epidemiology, health management, etc.).||ALL|
The additional use case ADD_Handle Health Professional's (HP) access to the current ePrescriptions is out of the current eHDSI scope. This use case refers to the possibility for the health professional (the dispenser) to consult the current prescriptions of the patient.
|12||ePrescription||The additional use case ADD_Handle the medicine newly prescribed in Country B is out of the current eHDSI scope. This use case refers to the possibility of prescribing medicine(s) in a country (B) when the patient comes from a different country (A) where he/she has a valid identification in terms of health care.||ALL|
Sealed prescriptions (or information): The decision of a patient to hide information (e.g. prescriptions or diagnosis related to HIV) is part of each country’s process. This document will not cover or solve the scenario where the patient goes to country B and decides to authorise the HP in that country to consult the hidden information.
Precautionary cancellation: The dispenser might decide s/he is unable to safely dispense a medicine and cancel the prescription temporarily, until the prescriber revises the prescription. As this is a process not implemented in every country, it is currently out of the scope of eHDSI.
|15||ePrescription||Pharmaceutical care: It cannot be assured that for the eHDSI, all the information needed for correct or proper Pharmaceutical care will be available. It is assumed that medication surveillance, as part of the pharmaceutical care, will be covered by other processes in the country where health care within the context of eHDSI is given. However, it is recommended that the current prescriptions could be accessed by the pharmacist.||ALL|
Narcotics: They have specific legislation and are too complicated to deal with at this stage.
Substitution of active ingredient, strength and/or pharmaceutical dose form: as countries have different legislation regarding this topic and it is a complicated matter to solve for the eHealth DSI, substitution will include the simplest possibilities with the lowest impact for patient safety namely brand name and package size.
Medicinal products which are prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the ‘magistral formula’ or extemporaneous preparations) or those prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy (commonly known as the ''officinal formula'' or ''extemporaneous preparations'').
It is out of the eHDSI scope to send back (from Country B to Country A), a copy of the original medicine dispensed (PDF).
Original dispensed medicine: